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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040409

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NDA 040409 describes ANEXSIA 5/325, which is a drug marketed by Specgx Llc and is included in one NDA. It is available from eight suppliers. Additional details are available on the ANEXSIA 5/325 profile page.

The generic ingredient in ANEXSIA 5/325 is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Eighty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 040409
Tradename:ANEXSIA 5/325
Applicant:Specgx Llc
Ingredient:acetaminophen; hydrocodone bitartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040409
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 040409
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANEXSIA 5/325 acetaminophen; hydrocodone bitartrate TABLET;ORAL 040409 ANDA SpecGx LLC 0406-0123 N 0406-0123-60
ANEXSIA 5/325 acetaminophen; hydrocodone bitartrate TABLET;ORAL 040409 ANDA SpecGx LLC 0406-0123 N 0406-0123-62

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;5MG
Approval Date:Oct 20, 2000TE:AARLD:No

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